510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013251Substantially Equivalent

Spirit 300

Caire, Inc., Burnsville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013251 is the FDA 510(k) clearance record for SPIRIT 300, a class II device, cleared for Caire, Inc. on under FDA product code BYJ (Unit, Liquid-Oxygen, Portable). FDA records list one 510(k) clearance for Caire, Inc. As of , FDA records show no recalls naming K013251.

Clearance record

Decision date
Received
(81 days to decision)
Product code
BYJ Unit, Liquid-Oxygen, Portable
Regulation
21 CFR 868.5655
Device class
Class II
Review panel
Anesthesiology
Applicant
Caire, Inc. 3505 County Rd. 42 W., Burnsville MN
510(k) summary
Summary
Third party review
Yes

Clearances, product code BYJ

Trailing 12 months

FDA records hold no clearances under product code BYJ in the trailing twelve months.

FDA records show no clearances under product code BYJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260